It may have been Halloween, and some participants may have been in costume, but the membership breakfast Tuesday morning for Day 3 of the 2017 ISPE Annual Meeting & Expo was all about receiving treats rather than playing tricks. The hallmark of each ISPE Annual Meeting, the breakfast reviews the past year’s accomplishments and celebrates outstanding members in eight categories.
Outgoing Board Chair Michael A. Arnold opened the session, welcoming participants and congratulating the 14 affiliates and chapters that achieved at least 1% membership growth in 2017.
Before calling the 2017 ISPE Annual General Meeting to order, Arnold thanked outgoing members of the Board for their service and dedication, introduced the new Board for 2017–2018, and recognized past Chairs.
Chair: Tim Howard
Vice Chair: Jim Breen
Treasurer: Frances Zipp
Secretary: Tom Hartman
Past Chair: Michael Arnold
Directors: Joanne Barrick, Peter Carbone, Tony Crincoli, Flemming Dahl, Kelly Keen, Christine Moore, Alice Redmond, Michael Rutherford, Fatma Taman, and Jörg Zimmermann; YP Representative: Caroline Rocks
As Arnold presented highlights from the past year, he took note of the Society’s evolution since 2013. “We’ve set the stage for the future and our finances remain strong and are directionally correct.” ISPE has seen a 74% growth in assets, 31% rise in investment reserves, and a 7.4% increase in revenue.
He reminded the audience of the commitment he made 14 months ago, when he assumed his office as Chair. “I said I’d listen to you, and that I would facilitate sound business decisions.” He then addressed some initiatives, including the creation of a Voice of the Customer initiative, an Operations Committee, and a Business Development Committee.
“I also said I would focus on four key areas: transparency, business diversity, collaboration, and strengthening our core,” he continued, outlining achievements in each area, including Women in Pharma, signing a memorandum of intent to create a new Eurasian Economic Union Affiliate, and creating the new ISPE Foundation.
“It has been a very, very busy year for the Board, staff, and volunteers,” said Arnold. “Volunteers are the fuel to the ISPE engine. Without you we wouldn’t have the credibility we have.”
Before handing the gavel, and a light saber, to incoming Board Chair Tim Howard, Arnold thanked ISPE volunteers, staff, members, and committee leaders for their leadership, commitment, and support; as well as the Board Executive Committee and members; Pfizer; and his wife, with whom he will celebrate 40 years of marriage in the coming weeks.
Howard began by saying “I’ve called on all past Chairs for advice and counsel during the past six years, and I’m humbled to be joining your group.”
He continued by saying “The list of folks who I have to thank is long and distinguished, so I’m going to recognize three special groups: the CAI Board of Directors and Bob Chew, for your support and mentoring; ISPE staff, for your passion and dedication; and my wife and children for their unwavering support.”
He commented that the magnitude of Arnold’s influence on the organization has been significant. “I have identified four areas of focus: continuity, affiliates and chapters, global reach/local relevance, and the ISPE foundation.”
Howard stated that he has already begun a conversation with Jim Breen, currently ISPE’s Vice Chair. “Jim and I have also started a dialogue on what’s important for the coming year. We want to feed the young professional (YP) pipeline, and focus on facilities of the future.” Howard also stated he wants to find ways to enhance member value by supporting the growth and promotion of two communities: Women in Pharma and YPs.
Howard then closed the business portion of the meeting and invited ISPE President and CEO John Bournas to the stage to kick off the awards ceremony. “I also want to thank Bob Matje and his committee for identifying today’s honorees.”
The awards ceremony began with the Student Poster Competition, which recognizes outstanding achievement from ISPE student members at the undergraduate and graduate levels. These student research projects are adjudicated at the Affiliate and Chapter levels; the top selections are invited to the Annual Meeting for the final presentation. Bournas recognized and applauded all participants before announcing the two winners. At the undergraduate level, Maria de Abreu Pineda from Stevens Institute of Technology represented the New Jersey Chapter. At the graduate level, Tanvi Joshi from Campbell University represented the Carolina–South Atlantic Chapter.
ISPE Affiliates and Chapters are instrumental in extending the membership experience locally. ISPE has 38 Affiliates and Chapters in its global network, and this year the committee opted to recognize two outstanding teams.
The first Affiliate and Chapter Excellence Award went to the ISPE San Francisco/Bay Area Chapter. Chapter Past President, David Bendet, and Chapter Manager, Kimberly Syre, accepted the award.
“The ISPE San Francisco/Bay Area Chapter has done outstanding work this year particularly in the areas of membership development and community affairs,” said Bournas.
“Additionally, the Community Affairs Committee has been very busy with several educational initiatives and fundraisers. One special initiative, The Chocolate Factory program, teaches fifth grade students in the Bay Area about the pharmaceutical industry. Teachers have expressed their gratitude for the program and have noted that it has been successful at stimulating student engagement long after the industry volunteers have completed their work.”
Bournas then announced that the second ISPE Affiliate and Chapter Excellence Award would go to the ISPE Singapore Affiliate. Past President Pierre Winnepenninckx accepted the award.
“The Singapore Affiliate attracts an impressive depth and breadth of volunteers and are very visible in the region,” said Bournas, “Its Annual Conference and Exhibition attracts attendees from 25 countries, including many Asia Pacific Affiliate Council (APAC) leaders and regulatory speakers.”
“ISPE Singapore Affiliate has very active membership recruitment and retention activities as well as programs to mentor and develop students and young professionals. Their planning teams enthusiastically embrace successful program ideas from other Affiliates and Chapters. Creation, development, and delivery of programs serving the needs of local members for this Affiliate is quite an achievement.”
More than 75 committees, councils, Communities of Practice (CoPs), and other teams support ISPE’s mission, and deliver value back to the membership. Two committees received the award this year.
The first Committee of the Year Award went to the Guidance Document Committee (GDC); Committee Chair Jim Brinkman, Senior Director, Pfizer Global Engineering accepted the award on the committee’s behalf.
“The GDC has had an active, impactful year advancing the technical influence of ISPE,” said Bournas. “The work of the GDC is a prime example of ISPE taking deliberate steps toward delivering on-demand access to ISPE knowledge and training to support execution and learning anywhere around the globe.”
The second Committee of the Year Award went to the GAMP® Data Integrity Special Interest Group (SIG) Leadership Team. Lorrie Vuolo-Schuessler, Manager in the Computer Systems Quality Assurance Department within Global Quality Assurance at GlaxoSmithKline accepted the award on the team’s behalf.
“The most significant impact of the DI SIG and its leadership culminated in the development and release in April 2017 of the ISPE GAMP® Records and Data Integrity Guide,” said Bournas. “This Guide was developed in roughly 15 months by a dedicated task team of industry experts and the SIG leadership.”
Bournas then presented the first of the “named awards,” ISPE’s most significant awards that honor members who have dedicated themselves to excellence and service to the industry and to ISPE.
The first award is named in honor of Max Seales Yonker, an active member, Society leader, and a relentless contributor to ISPE and to the industry. When her family and her ISPE family lost her to cancer in 2005, it seemed only fitting that her memory be honored with an award that recognizes that same commitment to Society service. “The memory of Maxine Yonkers reminds us that we are all patients … and it reminds me of the vital work that each one of you do to advance the development, production, and delivery of a safe and reliable drug supply,” stated Bournas.
He then announced the 2017 winner to thunderous applause: François Sallans, Vice President and Chief Quality Officer at Johnson & Johnson.
“François is known as a leader and visionary within the industry and international ISPE community and is valued by his colleagues as an executive that is committed to building and sustaining a corporate culture that puts the patient first.”
“A significant global example of François’s contributions is through his leadership in chairing the International ISPE Drug Shortages Team, which began in 2012. Through his drive and leadership, François worked with the team to assess and define the industry wide drug shortages issue, which has been reported as a significant public health issue that has the attention of regulators worldwide.”
Sallans, taking the stage, said he was “honored and speechless.”
“We have done a lot since 2012, but we have done nothing at the same time. In Barcelona, we discussed the way forward in drug shortages, and we were pretty satisfied with what we had done. And then in September, Mother Nature taught us a lesson to a degree we never anticipated. Until then, resilience was a vague and theoretical concept. Now we realized what it meant.”
“In Puerto Rico what I saw was a lesson in resilience. We found people helping each other. Collaborating. I talked to one technician who lost her house. And this person was in the plant after five days because she cared about the patients she had the privilege to serve. She’s an example of hundreds of people standing up and doing their job. I know you’ve seen it in your people, too. This is the health care industry at its best.”
The Richard B. Purdy Distinguished Achievement Award is presented to members who have made significant long-term contributions to ISPE. It is named after one of the Society’s founders and most accomplished member presidents.
“This year,” said Bournas, “the Richard B. Purdy Distinguished Achievement Award is presented to Bob Chew, President of Commissioning Agents.”
Chew served on the ISPE Board of Directors from 2004 to 2007, was Member of the Year in 2008, and has been a member of or has led more than 50 ISPE committees, task teams, author groups, and CoPs. He served on the task team that created ASTM E2500 to improve how the industry performs qualification, and was a member of the task team that updated ISPE’s Commissioning and Qualification Baseline® Guide. In addition to his ISPE Board of Directors terms, he has held 16 different volunteer leadership roles.
“I’m stunned,” said Chew as he accepted the award. “I know all the people who have come before me to get this award, but I’m not sure I can hold a candle to them. I’m a strong supporter of everything this Society does. We’re all about better serving the patient, better manufacturing processes. I’m truly honored to be a small part of helping advance the supply of medicine to our patients across the globe.”
The Joseph X. Phillips Professional Achievement Award is named in honor of Joe Phillips, longtime supporter of ISPE and a leader in establishing the Society as an “integrator” of industry and regulators, both during his years of service with the FDA and later when he became International Regulatory Affairs Advisor to ISPE.
“It honors an ISPE member who has made a significant contribution to the industry, not just ISPE,” said Bournas, before announcing the 2017 recipient: Bob Tribe. “Bob has been an invaluable resource as ISPE’s Asia-Pacific Regulatory Affairs Advisory. His relationship-building with regulatory agencies in that region has been extremely valuable to ISPE International, the affiliates in Asia-Pacific, and the Regulatory and Compliance Committee.”
Tribe was visibly moved by the recognition, especially, he said, because Joe Phillips was a friend and mentor., “I got to know Joe in the 1990s when he was FDA. In those days there were many GMPs for APIs. So I thought about getting people together to get one GMP for the whole world. And Joe was with me in that. You could say that I’m the grandfather of ICH Q7.”
Bournas then called Jim Breen, Vice President/Project Lead Biologics for Janssen Pharmaceuticals, Chair of the 2017 Facility of the Year Judging Team and incoming Vice-Chair of the ISPE International Board of Directors, to the stage to recognize the eight category award winners and three honorable mention projects selected for recognition by the Facility of the Year Award judges panel and to announce Overall Winner of the ISPE 2017 Facility of the Year Award.
“It has been my privilege to be part of a program that helps our industry fulfill the important mission of developing and delivering quality medications that are safe, effective, and reliably delivered to people around the globe,” said Breen. Tony Crincoli, incoming Chair of the Facility of the Year Award Judging Committee joined him on stage to present the 2017 Overall Winner. “This year’s winning project exemplified the application of technology and project delivery to create a step change in our industry’s operating model,” he said, before announcing the winner: Eli Lilly and Company.
David Sternasty, Vice President, Director of Production Site, accepted the award on Lilly’s behalf. “The most important thing a leader can do,” he said, “is find someone who’s doing something well and say, ‘do more of that.’ That’s what the FOYA awards do: they advance pharmaceutical engineering and say, ‘do more of that.’”
|2017 Facility of the Year Award||Eli Lilly and Company|
|Joseph X. Phillips Professional Achievement Award||Robert W. Tribe|
|Richard B. Purdy Distinguished Achievement Award||Robert E. Chew, PE|
|Max Seales Yonker Member of the Year Award||François Sallans, PharmD|
|Outgoing Board Chair||Michael A. Arnold, RPh|
|Outgoing Board Member||Joseph C. Famulare|
|Outgoing Board Member||Robert E. Matje, CPIP, PE|
|Outgoing Board Member||Christopher J. Reid|
|Affiliate and Chapter Excellence Award||ISPE San Francisco/Bay Area Chapter|
|Affiliate and Chapter Excellence Award||ISPE Singapore Affiliate|
|Committee of the Year||GAMP® Data Integrity Special Interest Group (SIG) Leadership Team|
|Mark E. Newton|
|Charlie C. Wakeham|
|Christopher H. White|
|Committee of the Year||Guidance Documents Committee|
|Chair: James M. Brinkman|
|Co-Chair: Mark E. Newton|
|Member: Christopher E. Ames|
|Member: John C. Berridge, PhD, CChem, FRSC|
|Member: Jeffrey A. Biskup|
|Member: Robert J E Bowen|
|Member: Jose Caraballo|
|Member: Chris Clark|
|Member: James J. Curry|
|Member: Bruce S. Davis|
|Member: Christopher Derrett|
|Member: Robert Dream|
|Member: Nicholas R. Haycocks|
|Member: Matthew McMenamin|
|Member: Patricia M. Melton, PhD|
|Member: Stephan T. Orichowskyj, PE, CPIP|
|Member: Maurice B. Parlane|
|Member: Simon C. Shelley|
|Member: Frank van der Steen|
|Member: Jwalant Vyas|
|Member: Stephanie Wilkins|
|Member: Steven J. Wisniewski|
|Member: James P. Wood|
|Undergraduate Student Poster Competition||Maria de Abreu Pineda, Stevens Institute of Technology, New Jersey Chapter|
|Graduate Student Poster Competition||Tanvi Joshi, Campbell University, CaSA Chapter|
In closing, Tim Howard said, “it is a pleasure to see so many accomplished members and partners doing such wonderful work, and I’d like to congratulate all of our award winners once again.”
He then reminded the audience that next year’s Annual Meeting will be held from 4 to 7 November at the Philadelphia Convention Center, and presented a video message from Philadelphia Mayor Jim Kenney.
As attendees prepared to leave, Howard reminded them not to miss the Tuesday Night Party, taking place aboard the USS Midway. “There will be food, drinks, tours of the ship, and great networking opportunities with friends and colleagues.”
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